Associate Director/Director, Project Leader of Non-clinical Studies

KEY ACCOUNTIBILITIES:

• Non-clinical project leader and biologics TOX/PK/IND expert responsibility.
• Manage, direct and lead pre-clinical projects in a team environment; Work with clients to proactively identify the right non-clinical strategy based on their unique program and help clients to design right studies, smartly coordinate the studies to move forward efficiently.
• Work closely with BD to support non-clinical contracts signed based on strong TOX/PK/IND background and communication skills.
• Monitor closely the progress of projects, coordinate with sponsors and internal experts to design appropriate studies to meet regulatory requirements, ultimately to meet the project needs; Stay on the top of project with continues scientific and technical support; Proactively identify potential issues and provide the constructive expert input.
• Serve as an expert for all TOX/PK/IND-related discipline within BioDev; Prepare document package for IND filing; Lead IND filings to NMPA, FDA, EMA, MHRA and globally; Search and prepare scientific references for project needs.
• Initiate issue-oriented agendas to facilitate effective team meeting discussion and able to summarize and provide guidance on follow-up strategies to ensure timely resolution of outstanding items.
• Provide supervision on Study Directors with other expertise including PK/TOX and regulatory filing; Coordinate all non-clinical studies and IND filing by leveraging all internal and external resources.

REQUIREMENTS:

• Expert in the field, PhD or equivalence in biomedical/pharmaceutical science with at least 5+ years’ experience in pharmaceutical/biotech industry in non-clinical development with strong toxicity expertise.
• Demonstrated successful leadership, planning and organizational skills with strong knowledge in pharmaceutical R&D from discovery to clinical development and regulatory registration.
• Familiar with relevant ICH, FDA, NMPA and EMA/OECD guidelines/regulations with hands-on experience on planning and execution of IND programs.
• Rich experience with regulatory authorities on various topics about TOX, PK and IND-enabling studies.
• Regulatory writing experience will be a plus.
• Team oriented work ethic and ability to work in cross-functional teams.
• Excellent written and oral communication skills, fluency in English and Chinese.

EDUCATION (Indicate the mini. requirement & preferred discipline):

• PhD in biology, immunology, pharmacology, toxicology or related field.

OTHER SKILLS, ABILITIES & EXPERIENCE:

• A driven, energetic individual with experience of operating to the professional standards of a large pharmaceutical company.
• Flexibility and entrepreneurial skills.
• Good people interaction skills, ability to influence to other departments.
• Outstanding presentation skills both verbally and in writing, able to communicate his/her points articulately.
• Role model, high level of integrity and honesty both internally and externally.